The labeling for Praluent (alirocumab; Sanofi and Regeneron) has been updated to including dosing information for patients with heterozygous familial hypercholesterolemia (HeFH) undergoing LDL apheresis. The recommended dose for these patients is 150mg once every 2 weeks. Praluent can be administered without regard to the timing of apheresis.
The dosing recommendation was based on data from a double-blind, placebo-controlled study conducted in 62 patients with HeFH undergoing LDL apheresis. Patients were randomized to Praluent 150mg every 2 weeks (n=41) or placebo (n=21) and were treated in combination with their usual LDL apheresis schedule for 6 weeks. Mean LDL cholesterol (LDL-C) at baseline (measured before apheresis) was 181mg/dL.
Results showed that at week 6, the mean percent change from baseline in pre-apheresis LDL-C was -53% in patients treated with Praluent compared with 1% in the placebo arm.
Praluent, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor antibody, is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C.
Praluent is supplied in single-dose prefilled pens or syringes in 75mg/mL and 150mg/mL dosage strengths.
For more information visit Praluent.com.